Draeger Medical, Inc. Recalls
Showing 1-20 of 42 recalls
Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog Number: 8416400
Cybersecurity Improvement Action-not equipped against potential cyber security threats
Draeger issued "Urgent Medical Device Correction Notices" on 2/14/22 to the Director, Clinical Engineering and Risk Manager via FedEx with tracking/confirmation of delivery. Letter states reason for recall, health risk and action to take: Continue to follow the recommendations in the instructions for use: o Limit or control physical access to the abovementioned ventilators. o Do not connect any non-approved devices to the USB, LAN and DVI interfaces. o Be attentive to notifications, alarms, and alerts Consider closing/covering all unused USB, LAN and DVI interfaces Should you decide to close/cover unused interfaces, Draeger offers to provide tools upon request to cover or close these data interfaces of the ventilators free of charge. For the intended and authorized use of the interfaces the USB locks and interface covers can be removed with the provided tool. To order this material please contact Dragger Customer Success via phone between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 1 at the prompt, the 2), via fax at 1-215-723-5935, or via email at US-Medical@draeger.com. You will need to know the material number to order, which is dependent on the model of the C500 Cockpit that is installed on your V500/VN500 Ventilator. If you have any questions regarding the operation of your Evita V500 or Babylog VN500, please contact Drager Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1).
Seattle PAP Plus, MP02260
Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.
The firm distributed recall notifications to consignees via FedEx starting on 4/17/2023. Consignees are instructed to immediately stop use of affected devices, inspect current stock, and quarantine any affected devices to prevent use. Alternative therapy for patients should be instituted as soon as possible and ensure all users of affected devices within consignee organizations are aware of the recall, with copies being forwarded if devices were further distributed. To replace or return unused products, consignees are to call Draeger Customer Success between 8:00 AM - 6:00 PM EST, Monday thru Friday, at 1-800-437-2437 (option 2, then option 1), or via email at US-Medical@draeger.com. A Return Materials Authorization and pre-paid shipping label will be provided upon request. Any additional questions regarding the recall communication may be directed to Mr. Michael Kelhart between the hours of 8:00 AM - 4:30 PM by phone at 267-664-1131 or by email at mike.kelhart@draeger.com.
Critical Care Ventilator, Catalog Number(s): 8422300: Evita V600 - Product Usage: used for treating patients who require temporary or longer term respiratory support for different medical reasons.
Three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800: 1. Restart of ventilation unit. 2. Incorrect FiO2 high and FiO2 low alarms. 3. SmartCare/PS (SC/PS) suspends weaning
In April, 2021, Draeger issued an Urgent Medical Device Correction notice to customer via letter notifying them that Draeger became aware of three separate and unrelated problems attributed to the software used in the Evita V600, Evita V800, Babylog VN600 and Babylog VN800:
Draeger Fabius MRI Anesthesia Machine, Catalog Number 8607300
26 Fabius MRI Anesthesia machines were distributed with internal hoses routing Oxygen to the Oxygen Flush and Oxygen Flow Control interchanged. If the hospital O2 Central supply pressure is not stable, the O2 fresh gas flow could deviate from the adjusted value. If the deviation is not noticed, insufficient oxygenation of the patient may occur.
On December 17, 2021, the firm notified customers via Urgent Medical Device Correction Notice. Customers were instructed to do the following: Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Correction Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. A Drger Service representative will contact you to arrange a date for the correction to be performed free of charge. Until the repair has been concluded you may continue using the device under constant supervision as long as appropriate O2-monitoring is in place and a suitable alarm limit is set. Please consider a suitable buffer when adjusting the O2 flow. If you have any questions regarding the operation of your Fabius MRI Anesthesia Machine, please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437- 2437 (press 2 at the prompt, then 2, then 2 again). If you have any questions regarding this recall communication, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Drager SafeStar 55, Catalog No. MP01790
Possible occlusion of filters due to manufacturing error.
The firm distributed a notification titled "URGENT MEDICAL DEVICE RECALL" by mail on 05/16/2022, in which it informed customers of the voluntary recall of Lot LT2103 of Draeger SafeStar 55 Breathing System Filters, Ref. No. MP01790, UDI-DI 04048675026785. The firm states that this recall is being initiated in response to becoming aware of a complaint in which a patient became hypoxic and had to be resuscitated while under anesthesia using the Draeger SafeStar 55 Breathing System Filter from the affected lot. The firm indicated that a manufacturing feature that automatically destroys filters that fail acceptance testing was disabled during servicing, which resulted in filters having to be hand sorted during manufacturing of Lot LT2103. Drager is asking customers to check their inventory for SafeStar 55 breathing system filters from Lot LT2103. If any affected product is on hand, customers are to call Draeger Customer Service at 1-80-437-2437, fax at 1-215-723-5935, or email at US-Medical@draeger to obtain free replacement of product. If any affected product is on hand, customers are to segregate and quarantine product until Draeger's provision of a return materials authorization and pre-paid shipping labels. Draeger also asks customers to make the recall notification available within their organization and to forward a copy if product was further distributed. A Customer Acknowledgement Form was provided with the notification for all customers to complete and return. Customers with any questions are to contact Michael Kelhart, Quality Director, between the hours of 8:00 AM and 4:30 PM EST at 1-800-437-2437, press 1, then 32349.
VentStar Anesthesia (N) 180 - Drager Breathing Circuits/Anesthesia Sets Order Number: MP00333 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
Draeger Inc. (US) issued Urgent Medical Device Recall Letter via Certified Mail on January 29, 2021. The letter states reason for recall, health risk and action to take: Please check the quality of the adhesive joint before use by holding the Y-piece with one hand and then pulling (not twisting) each of the two hoses one after another so that the hose just starts to stretch visibly. Hoses that you have tested in this manner may be used if they pass the leakage test before use. Only use the hoses with devices that we have declared compatible in the Instructions for Use or accessories list of the basic device. Ensure that the patient is adequately monitored and select suitable alarm limits. During installation and operation, make sure to avoid any unnecessary tensile forces, and do not use the hoses for longer than is specified in the Instructions for Use. Please inspect your existing stock before use by following the above inspection instructions. Please also complete and return the attached Customer Reply and Order form to confirm to us that you have received this information. If you wish, we will be happy to replace any of your unused stocks that were manufactured between 01.01.2018 and 13.11.2020. The form may also be used to order Free of Charge replacements. Questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
Evita V500 Ventilator with Installed CO2 Measurement Option-Intended for the ventilation of adult,pediatric and neonatal patients. Catalog Number: 8416400
Software 2.51 and Lower with Installed CO2 Measurement Option, may result in Restart of the Ventilator, brief cessation of ventilation can occur and loss of PEEP for approx. 8 seconds
Drager issued Urgent Medical Device Recall letter on 9/10/21 via FedEx with tracking (confirmation of delivery). Letter states reason for recall, health risk and action to take: The release of a corrected software is expected to be available in Q4 of 2021. Once the software is available, your local Drger Service representative will contact you to arrange a date for the software update to be performed free of charge. According to our records, at least one of the mentioned affected devices has been shipped to your facility. Please ensure that all users of the above-mentioned products and other concerned persons within your organization are made aware of this Urgent Medical Device Recall Notice. If you have provided the products to third parties, please forward a copy of this information. Please keep this information at least until the corrective measure has been completed. Please also complete and return the attached Customer Acknowledgment Card to confirm to us that you have received this information. If you have any questions regarding the operation of your Evita V500 or Babylog VN500, please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 2 at the prompt, then 2, then 1).
Fabius GS Premium Anesthesia Machine; Cat. no. 8607000 Product Usage: Inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series machines are equipped with a compact breathing system; providing fresh gas decoupling, PEEP, and pressure limitation. The following ventilation options are available: Volume Controlled Ventilation Pressure Contr
The Draeger anesthesia device may be able to dose 100% N2O. In the event of a fault, the S-ORC module would not prevent setting an N2O flow that would result in a hypoxic mixture from being dosed to the patient. Potential adverse outcomes include death of the patient.
On May 24, 2018, the firm issued Urgent Medical Device Recall letters to affected end users (medical facilities) via certified mail. The letter identified the affected product, problem and actions to be taken. The recalling firm stated that they are currently manufacturing replacement parts for all potentially affected devices, which will be installed as part of the next service. The firm's Service dept. will contact end users to arrange the replacement Free of Charge In addition, end users were asked to complete and return a Customer Reply Card to acknowledge the receipt of this information. If you have any questions regarding this recall please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). For questions regarding the operation and/or servicing of your Draeger anesthesia machine please contact DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
Optional PS500 Power Supply Unit for the Evita V500 Ventilator and Babylog VN500 Ventilator. Babylog VN500 is a ventilation unit intended for the ventilation of neonatal and pediatric patients.
The firm became aware of cases in which the battery run times of the optional PS 500 power supply unit with the Infinity Workstation Critical Care (Evita Infinity V 500) were unexpectedly short due to the design of the charging algorithm in the current software. Devices used for patient transport will be a priority.
Draeger Medical, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated November 2015 to all affected consignees. The letter identified the product, problem, and actions to be taken by the customers. The Battery Charging Software will be updated and, if necessary, the batteries replaced in all affected devices Free of Charge.
Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation.
The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device.
Draeger Medical, Inc. will send an Urgent Medical Device Recall Letter to consignees in a method that confirms delivery. For consignees that have received new devices with firmware version 1.50 (127 devices) or through device updates (644 devices; reference Recall Z-0436-2016), those devices will be downgraded to firmware version 1.49 and the batteries replaced. Batteries will continue to be replaced for all consignees every six months until a final solution is available.
Fabius MRI, anesthesia machine, catalog no. 8607300 Product Usage: The products are inhalation anesthesia machines for use in operating, induction and recovery rooms. They may be used with O2, N2O, and AIR supplied by a medical gas pipeline system or by externally mounted gas cylinders. Fabius series anesthesia machines are equipped with an electrically driven and electronically controlled ventilator and monitors for airway pressure (P), volume (V), and inspiratory oxygen concentration (FiO2).
The automatic ventilation may fail if the position detection of the motor is disturbed. If the ventilator cover is damaged, manual ventilation may also fail.
On March 1, 2018, the recalling firm notified affected customers via an Urgent Medical Device Recall letter. The recalling firm stated that customers would receive replacement motors for potentially affected devices. Until the replacement occurred, customers were instructed to continue to operate their devices with the usual attention and make sure that a manual resuscitator for emergency ventilation is kept ready according to the instructions for use. Customers were also supplied with a reply card to indicate that they had received the notification. Customers with questions about the letter were directed to call Michael Kelhart between 8AM-4:30PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349). Questions regarding the operation and/or servicing of the Draeger Fabius anesthesia machine were directed to DraegerService Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437 (press 4 at the prompt then 4 again).
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
On Friday 12/21/2018, Draeger, Inc. issued an "Urgent Medical Device Recall Notification" and Customer Reply and Order Form to consignees via Certified Mail. Two Recall Notifications/Customer Reply and Order forms will be sent to each facility. One will be addressed to Risk Manager. The other will be addressed to Purchasing/Materials Manager. Based on customer response, Draeger will replace any affected Breathing Circuits/Anesthesia Sets Free of Charge. Customers are advised to take the following action: - Before each use, and also after any temporary disconnection, please check whether the breathing circuit is assembled such that both the inspiratory and the expiratory connector of the ventilator or anesthesia machine are each connected to the y-piece. - Please inspect your existing stock by following the inspection instructions in the attachment and complete and return the attached Customer Reply and Order form via fax to:215-372-2940 or email to:denise.frey@draeger.com to confirm to us that you have carried out the inspections. The form is also used to order Free of Charge replacements if you find any breathing circuits that have been incorrectly pre-assembled. - The correct set-up of the breathing circuit is illustrated in the Instructions for Use not only of the hose systems but also of the anesthesia machines and ventilators. Connection to the device must be checked prior to use. An incorrectly pre-assembled breathing circuit can be detected because it will not be a single cohesive hose system but two separate sub-systems. Customers with questions, please call 1-800-437-2437 (press 1 at the prompt, then 32349).between the hours of 8:00 AM 4:30 PM EST.
Carina Ventilator, ventilator. Catalog no. 5704110. Long-term ventilator for treatment in hospitals by a qualified medical personnel.
The valve assembly material may become corroded due to insufficient cleaning by a supplier. There is a risk of the breathing gas becoming contaminated in the affected devices.
On April 27, 2018, the recalling firm contacted its consignees by telephone prior to sending out Urgent Medical Device Recall notifications via e-mail. Customers were instructed to remove affected devices from operation immediately. The firm provided replacement devices so customers could send their affected ventilator to the firm's repair center for update once the required parts were available. Customers were also asked to inform all affected users at each site. If you have any questions regarding this letter please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437. For questions regarding the operation and/or servicing of your Carina Ventilator please contact Drger Service Technical Support between the hours of 8:00 AM 8:00 PM EST at 1-800-437-2437.
Oxylog 3000, Disposable Pediatric Patient Circuit, Catalog Number: 5704964 The VentStar Oxylog 3000F disposable pediatric patient breathing circuit is used with the Drger Oxylog 3000 and Oxylog 3000 plus Emergency Transport Ventilators.
Isolated episodes of leakage at the check valve were found
Drager sent an Urgent Medical Device Recall letter dated May 31, 2016 and Customer Reply and Order Card to all customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to inspect stock and dispose of affected products. For questions regarding this letter call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger device/accessory contact DrgerService Technical Support at 1-800- 543-5047 (press 4 at the prompt).
Fabius MRI Anesthesia Machine; Fabius MRI is an inhalation anesthesia machine for use in MRI environments in operating, induction and recovery rooms.
the Fabius MRI or parts of the system were attracted by the magnetic field of the MRI. If the Fabius MRI is positioned too close to the MRI, its parts can be loosened as a result of the magnetic force of the MRI.
Draeger Medical sent an Urgent Medical Device Recall Letter, dated June 2015, and Instructions for Use Supplement (one supplement for each Fabius MRI Anesthesia Machine at the facility) to end users. The letter identified the affected product, problem and actions to be taken. For questions regarding the recall letter contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of the Drger Fabius MRI anesthesia machine contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Emergency Transport Ventilator Oxylog 2000 Plus Ventilator Catalog Number: 5705080. Volume controlled emergency and transport ventilator with pressure support.
Drager became aware of situations where the error message "Poti unplugged" was generated causing acoustic and visual alarms, the breathing system releases pressure and the ventilation function stops operating.
The firm, Draeger Medical, Inc., sent an "Urgent Medical Device Recall" letter dated 12/21/2015 and a copy of the Instructions for Use (IFU) Supplement to consignees in a method that confirms delivery. The letter described the product, problem and actions to be taken. The consignees were instructed to include a copy of the supplement with their Oxylog IFU; inform all affected users in their facility; and contact Draeger Customer Support at 1-800-543-5047 (press 4 at the prompt) to obtain additional copies of the IFU Supplement Free of Charge. If there are any questions regarding this letter, please contact Michael Kelhart at 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger Oxylog ventilator please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt). On 12/09/2016, Draeger mailed an Urgent Medical Device Recall notification letter to affected customers to inform them of a revised new software for the Oxlog 3000/3000plus (version 1.06 for Oxylog 3000 plus and version 1.23 for Oxylog 3000) that reduces the impact of the error condition. Customers will be contacted by a Drager Service Representative to schedule a time to perform the software update free of charge. The new software changes the device behavior in the event of the error (a controller failure). With the new software, in the event of a controller failure, ventilation will not stop. The device will continue to ventilate with the last setting. An alarm will annunciate and be displayed, alerting the user of the controller failure.
Perseus A500 Anesthesia Workstation, MK06000. Intended for use in anesthetizing adults, children, and neonates and can be used for automatic and manual ventilation, pressure-supported spontaneous breathing, and spontaneous breathing.
There is a potential problem with the device main power switch of the Perseus A500 Anesthesia Workstation. The device power switch may spontaneously fail during use, causing one of the following to occur: 1. The workstation has a fresh gas delivery failure and a ventilator failure with respective alarms. 2. The workstation shuts down completely with an audible alarm.
Draeger Medical, Inc. sent Urgent Medical Device Recall Letters, dated November 2015, to consignees on November 10, 2015. The letter identified the affected device and the reason for the recall. The device power switch of the affected workstations must be replace. Customers should refer to the list of affected serial numbers provided. A Drager Service Representative will contact customers to schedule the replacement free of charge, as soon as new switches are available. Until the replacement takes place, the workstation may only be operated under continuous supervision. Increased attention is necessary to notice the potential failure case early. All affected users should be informed. Customers can contact Michael Kelhart at 1-800-543-5047, (press 1 at the prompt, then 2, then 32349), with questions pertaining to the letter. Contact Drager Service Technical Support at 1-800-543-5047 for questions regarding the operation or servicing of the Drager Perseus A500.
PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended for the ventilation of adult, pediatric and neonatal patients.
The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.
Draeger Medical, Inc. sent an Urgent Medical Device Recall Letter, dated July 2015, to end users to inform them of the issue and provide interim instructions to avoid the associated risk to patients. All PS500 batteries will be exchanged free of charge.
Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled. Product Usage: Babytherm 8004/8010 is an open care infant warmer system for warming premature babies, neonates and infants with a body weight of up to 8 kg (17.6 lbs). The device is intended for use in delivery rooms, operating rooms, maternity and obstetric units, neonatal and pediatric wards, neonatal and pediatric intensive care u
Risk associated with operating the device in skin temperature mode with temperature sensors attached but no patient connected.
Drager mailed to customers an Urgent Medical Device Recall Notification Letter dated June 22, 2016 to affected customers. The letter identified the affected product, problem information on how to operate the device and replacement of parts information. For questions regarding this letter please call 1-800-543-5047 (press 1 at the prompt, then 2, then 32349). For questions regarding the operation and/or servicing of your Drger Babytherm 8004/8010 please contact DrgerService Technical Support at 1-800-543-5047 (press 4 at the prompt).
Draeger D-Vapor/ D-Vapor 3000 Vaporizers with Baxter Desflurane Agent and Bottles. Catalog # M35500 (D-Vapor) and M36700 (D-Vapor 3000). Anesthesia Vaporizer
Operators noticed unwanted release of evaporating anesthetic agent at the end of the filling procedure. Eye contact with volatile anesthetics can result in serious irritation. Immediate eye flushing and consultation of a physician is recommended. Updated Material Safety Data Sheets (MSDS) for Desflurane recommend wearing safety glasses when handling these substances.
Drager mailed a "Medical Device Safety Alert" dated April 21, 2016, to customers informing them of the problem and provided instructions for the "correct filling procedure" and recommendations on how to prevent evaporation and spraying of Desflurane after bottle release to resolve the "High Friction of gas bottle valve" problem.